DPX-Survivac and Pembrolizumab With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (VITALIZE)

April 5, 2023 updated by: ImmunoVaccine Technologies, Inc. (IMV Inc.)

A Phase 2b, Open-label, Multicenter, Randomized Parallel-Group, Two-Stage, Study of an Immunotherapeutic Treatment DPX-Survivac and Pembrolizumab, With and Without Intermittent Low-Dose Cyclophosphamide, in Subjects With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (VITALIZE)

This is a Phase 2b, randomized, open label study to assess the safety and efficacy of DPX-Survivac and pembrolizumab, with and without low-dose cyclophosphamide (CPA) in subjects with relapsed or refractory DLBCL.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 2b, randomized, open label study to assess the safety and efficacy of DPX-Survivac and pembrolizumab, with and without low-dose cyclophosphamide (CPA) in subjects with relapsed or refractory DLBCL.

The study will enroll up to 102 subjects. Eligible subjects will be randomized (1:1) to receive:

  • Arm 1: DPX-Survivac, pembrolizumab and intermittent, low-dose CPA; or,
  • Arm 2: DPX-Survivac and pembrolizumab

All subjects will receive two 0.5 mL doses of DPX-Survivac 3 weeks apart on day 7 (D7) and D28 followed by up to twelve 0.1 mL doses of DPX-Survivac, 8 weeks apart (Q8W).

All subjects will receive pembrolizumab intravenously (IV) at a flat dose of 200 mg starting at D7 and on day 1 of each 3-week cycle thereafter (i.e., D28, D49, D70 etc.) (Q3W).

For subjects randomized to Arm 1, intermittent oral CPA at a dose of 50 mg twice a day (BID) is administered from D0 to D6 (7 days) followed by 7 days off. This 14-day cycle of "7 days on and 7 days off" will be repeated until the end of study treatment.

Study Type

Interventional

Enrollment (Anticipated)

102

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Westmead, Australia, 2145
        • Recruiting
        • Westmead Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
    • Victoria
      • Melbourne, Victoria, Australia, 3002
        • Recruiting
        • Epworth Freemasons Hospital
      • Melbourne, Victoria, Australia, 3128
        • Recruiting
        • Box Hill Hospital
  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7H 4H4
        • Recruiting
        • Saskatoon Cancer Center
  • France
      • Bobigny, France, 93000
        • Recruiting
        • Hopital Avicenne
      • Nancy, France, 54000
        • Recruiting
        • Centre D'Oncologie de Gentilly
      • Nantes, France, 44277
        • Recruiting
        • Hôpital privé du Confluent
      • Nice, France, 06189
        • Recruiting
        • Centre Antoine Lacassagne
      • Paris, France, 75015
        • Recruiting
        • Hôpital Necker
      • Paris, France, 75012
        • Recruiting
        • Hopital Saint-Antoine
      • Paris, France, 75013
        • Recruiting
        • Hôpital de la Pitié-Salpêtrière
      • Pessac, France, 33600
        • Recruiting
        • CHU Bordeaux- Hopital Haut Levèque
      • Périgueux, France, 24019
        • Recruiting
        • Centre Hospitalier de Périgueux
      • Saint-Quentin, France, 02321
        • Recruiting
        • Centre Hospitalier de Saint-Quentin
  • Hungary
      • Debrecen, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont
      • Nyíregyháza, Hungary, 4400
        • Recruiting
        • SzSzBM Korhazak es Egyetemi Oktatokorhaz
        • Contact:
        • Principal Investigator:
          • Laszlo Rejto, MD
  • New Zealand
    • Auckland Province
      • Auckland, Auckland Province, New Zealand, 0622
        • Recruiting
        • North Shore Hospital
    • Manawatu
      • Palmerston North, Manawatu, New Zealand, 4414
        • Recruiting
        • Palmerston North Hospital
  • Poland
      • Gdynia, Poland, 85-519
        • Recruiting
        • Szpitale Pomorskie Sp. z o. o.
        • Principal Investigator:
          • Wanda Knopińska-Posłuszny, MD
        • Contact:
      • Legnica, Poland, 59-220
        • Recruiting
        • Wojewodzki Szpital Specjalistyczny w Legnicy
      • Olsztyn, Poland, 10-228
        • Recruiting
        • SP ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
      • Skórzewo, Poland, 60-185
        • Recruiting
        • Centrum Medyczne Pratia Poznan
      • Warszawa, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii, Skłodowskiej-Curie
        • Principal Investigator:
          • Jan Walewski, MD
        • Contact:
  • Romania
      • Bucharest, Romania, 022328
        • Recruiting
        • Bucharest Oncology Institute "Prof.Dr.Al. Trestioreanu"
        • Contact:
        • Principal Investigator:
          • Laura-Aifer Calustian, MD
      • Cluj-Napoca, Romania, 400015
        • Recruiting
        • The Oncology Institute "Prof. Dr. Ion Chiricuţă" I.O.C.H.
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • University Clinical Center of Serbia
      • Kragujevac, Serbia, 34000
        • Recruiting
        • University Clinical Center Kragujevac
      • Sremska Kamenica, Serbia, 21204
        • Recruiting
        • Oncology Institute of Vojvodina
      • Zemun, Serbia, 11080
        • Recruiting
        • Clinical Hospital Center Zemun
  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital Santa Creu i Sant Pau
      • Burgos, Spain, 09006
        • Recruiting
        • Hospital Universitario de Burgos
      • Sevilla, Spain, 41013
        • Recruiting
        • Hospital Universitario Virgen del Rocío
  • United States
    • California
      • Fountain Valley, California, United States, 92708
        • Recruiting
        • Compassionate Cancer Care Medical Group
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Withdrawn
        • Boca Raton Regional Hospital
      • Hollywood, Florida, United States, 33021
        • Withdrawn
        • BRCR Medical Center Inc.
      • Plantation, Florida, United States, 33322
        • Withdrawn
        • BRCR Medical Center Inc.
      • Saint Petersburg, Florida, United States, 33709
        • Withdrawn
        • Comprehensive Hematology and Oncology
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Blood and Marrow Transplant Group of Georgia
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University Health Melvin and Bren Simon Cancer Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane Cancer Center Office of Clinical Research
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Oncology Hematology West, PC dba Nebraska Cancer Specialists
    • New Mexico
      • Santa Fe, New Mexico, United States, 87505
        • Recruiting
        • Christus St. Vincent Regional Cancer Center
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • Brody school of Medicine at East Carolina University
    • Ohio
      • Canton, Ohio, United States, 44718
        • Withdrawn
        • Gabrail Cancer Center Research
      • Toledo, Ohio, United States, 43623
        • Recruiting
        • Toledo Clinic Cancer Center
      • Toledo, Ohio, United States, 43614
        • Withdrawn
        • University of Toledo Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • Allegheny Health Network (AHN) West Penn Hospital
      • West Reading, Pennsylvania, United States, 19611
        • Recruiting
        • Reading Hospital - McGlinn Cancer Institute
    • South Dakota
      • Watertown, South Dakota, United States, 57201
        • Withdrawn
        • Prairie Lakes Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Adults ≥ 18 years of age who are willing and able to provide written informed consent
  • Have an ECOG performance status of ≤ 1. Subjects with an ECOG performance status of 2 may be enrolled with Medical Monitor approval.
  • Pathologically confirmed diagnosis of DLBCL, as defined by the 2016 World Health Organization classification including DLBCL NOS high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, Epstein-barr virus (EBV) positive DLBCL, and T cell rich B cell lymphoma (TCRBCL). Subjects with DLBCL transformed from indolent lymphoma (except for Richter's transformation) are eligible.
  • Subjects must have progressive disease following at least two (2) lines of prior systemic therapy for DLBCL; prior treatment must have included an anthracycline and rituximab (or another CD20-targeted agent).
  • Subjects must have failed or be ineligible for ASCT or CAR-T
  • Have at least one bi-dimensionally measurable lesion per Lugano (2014)
  • Willing to provide pre-treatment and on-treatment tumor biopsy tissue.
  • Meet protocol-specified laboratory requirements
  • Life expectancy > 3 months.

Key Exclusion Criteria:

  • Primary CNS lymphoma or active secondary CNS involvement and/or lymphomatous meningitis
  • Chemotherapy, immunotherapy, major surgery, or investigational agent treatment within 28 days of D0 or 5 half-lives, whichever is shorter
  • Radiotherapy within 14 days of day 0
  • Autologous stem cell transplant (ASCT) within ˂100 days prior to D0
  • Chimeric antigen receptor T cell (CAR-T) therapy within ˂28 days prior to D0
  • Diagnosis of immunodeficiency disorder or history of active autoimmune disease that has required systemic treatment in the past 2 years
  • Uncontrolled significant active infections (controlled Hepatitis B, Hepatitis C, or HIV may be eligible)
  • Prior history of malignancy other than eligible lymphoma sub-types, unless the subject has been free of the disease for ≥ 2 years prior to the start of study treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: DPX-Survivac, pembrolizumab, CPA
Subjects will receive two 0.5 mL doses of DPX-Survivac three weeks apart followed by up to twelve 0.1 mL doses eight weeks apart. Pembrolizumab will be administered on the first day of every three week cycle at a flat dose of 200 mg. CPA will be self-administered 50 mg BID for 7 days on and 7 days off starting on D0.
Drug: DPX-Survivac
SC injection on D7 and D28, then every 8 weeks
Other Names:
  • maveropepimut-S
Drug: Pembrolizumab
IV infusion every 3 weeks
Other Names:
  • Keytruda
  • MK-3475
Drug: CPA
50 mg twice daily, week on then week off
Other Names:
  • Cytoxan
  • Procytox
  • Intermittent, low-dose cyclophosphamide
Experimental: Arm 2: DPX-Survivac, pembrolizumab
Subjects will receive two 0.5 mL doses of DPX-Survivac three weeks apart followed by up to twelve 0.1 mL doses eight weeks apart. Pembrolizumab will be administered on the first day of every three week cycle at a flat dose of 200 mg. Subjects randomized to Arm 2 will not receive CPA.
Drug: DPX-Survivac
SC injection on D7 and D28, then every 8 weeks
Other Names:
  • maveropepimut-S
Drug: Pembrolizumab
IV infusion every 3 weeks
Other Names:
  • Keytruda
  • MK-3475

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR) in each of the study arms
Time Frame: Approximately 24 months
Centrally evaluated using Lugano (2014)
Approximately 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Adverse Events using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 in each of the study arms
Time Frame: Approximately 24 months
Approximately 24 months
Duration of response (DOR) in each of the study arms
Time Frame: Approximately 24 months
Centrally evaluated using Lugano (2014)
Approximately 24 months
Time to response in each of the study arms
Time Frame: Approximately 24 months
Centrally evaluated using Lugano (2014)
Approximately 24 months
Progression-Free Survival in each of the study arms
Time Frame: Approximately 48 months
Centrally evaluated using Lugano (2014)
Approximately 48 months
Disease control rate (DCR) in each of the study arms
Time Frame: Approximately 24 months
Centrally evaluated using Lugano (2014)
Approximately 24 months
Complete response (CR) rate in each of the study arms
Time Frame: Approximately 24 months
Centrally evaluated using Lugano (2014)
Approximately 24 months
Changes in Patient Reported Outcomes using the FACT-Lym Assessment
Time Frame: Approximately 24 months
The FACT-Lym is a validated questionnaire that consists of a 27-item general core questionnaire (i.e., Functional Assessment of Cancer Therapy - General [FACT-G]) and a 15-item disease-specific questionnaire (Lymphoma Subscale).
Approximately 24 months
Changes in Patient Reported Outcomes using the EQ-5D-5L Assessment
Time Frame: Approximately 24 months
The EQ-5D-5L is a 5-item measure that can be used to describe and value current overall health consisting of 5 items assessing mobility, self care, usual activities, pain/discomfort, and anxiety/depression.
Approximately 24 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR) based on PD-L1 expression
Time Frame: Approximately 24 months
Centrally evaluated using Lugano (2014) and central assessment of PD-L1 using validated 22C3 assay
Approximately 24 months
Time to next treatment (TTNT) in each of the study arms
Time Frame: Approximately 48 months
Approximately 48 months
Overall survival (OS) in each of the study arms
Time Frame: Approximately 48 months
Approximately 48 months
Time to second objective disease progression (PFS2) in each of the study arms
Time Frame: Approximately 48 months
Approximately 48 months
Cell mediated immune response
Time Frame: Approximately 24 months
Approximately 24 months
Changes in immune cell infiltration in tumor biopsies
Time Frame: Approximately 24 months
Approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImmunoVaccine Technologies, Inc. (IMV Inc.)

Collaborators

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2021

Primary Completion (Anticipated)

October 1, 2024

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

May 28, 2021

First Submitted That Met QC Criteria

June 3, 2021

First Posted (Actual)

June 10, 2021

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 5, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P1605-SUR-D23
  • KEYNOTE-C54 (Other Identifier: Merck Sharp & Dohme Corp.)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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